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Community-dwelling Older AdultsNCT05887648

Effect of Singapore-contextualized Dance-based Exergame Among Community-dwelling Older Adults

A study testing SinDance in people with Community-dwelling Older Adults, run by National University of Singapore at 5 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aims of the research are to develop an age-appropriate and culturally sensitive older person-centered, Singapore-contextualized Dance-based Exergame (SinDance), and to pilot test its effectiveness in improving physical function and activity daily living (ADL) and reducing depressive symptoms and falls among… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Community-dwelling Older Adults
What is being tested?
SinDance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesSingapore
Study dates
5 Apr 2023to 24 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 60 and above
  • Living in the community
  • Independent without use of walking aids
  • able to read and understand English or Chinese
  • TUG < 30s
  • Mini-Cog test score of 3 and above

Who cannot join

  • Are suffering from mental disorders or cognitive impairment that will prevent individuals from understanding the study and performing the exergame correctly and safely (e.g. Alzheimer's disease)
  • Mini-Cog less than 3
  • have a pre-existing medical condition that prohibits exercise, or prevents the individual from performing the exergame correctly and safely, including but not limited to:
  • chest pain or chest tightness during physical activities (e.g. walking, climbing stairs, doing household chores or similar activities
  • heart failure
  • currently experience dizziness or light-headedness, uncontrolled/unstable high blood pressure
Show all 12Show fewer
  • have physical limitations, for examples:
  • wheelchair bound
  • pain, stiffness or swelling that will prevent the individual from doing what he/she wants or need to do
  • feel unsteady, use an assistive device while standing or walking
  • TUG equal or more than 30 seconds
  • have visual or hearing impairments.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Singapore5 sites
  • Lions Befrienders Active Ageing Centre @ CLEMENTI 344

    Singapore, 120344

  • Lions Befrienders Active Ageing Centre @ CLEMENTI 366/367

    Singapore, 120366

  • Lions Befrienders Active Ageing Centre @ CLEMENTI 420A

    Singapore, 121420

  • Lions Befrienders Active Ageing Centre @ Bendemeer 32

    Singapore, 330032

  • Lions Befrienders Active Ageing Centre @ Tampines 499C

    Singapore, 523499

Other trials in Singapore

About this study

Official title: Effect of Singapore-contextualized Dance-based Exergame (SinDance) in Promoting Physical Function and Reducing Depressive Symptoms and Falls Among Community-dwelling Older Adults: A Randomised Controlled Trial

The aims of the research are to develop an age-appropriate and culturally sensitive older person-centered, Singapore-contextualized Dance-based Exergame (SinDance), and to pilot test its effectiveness in improving physical function and activity daily living (ADL) and reducing depressive symptoms and falls among community-dwelling older people. It is hypothesized that participants in the SinDance will have: (1) improved postural balance, muscle strength, and ADL; and (2) reduced depressive symptoms, fear of falling, and number of falls, compared to those in the control group.

The research will be structured as a two-phase study.

Read more
  1. In Phase one, development of the SinDance system will be undertaken.
  2. In Phase two, a pilot randomized control trial will be conducted to evaluate the feasibility and potential effectiveness of the newly developed SinDance exergame on the proposed outcomes.
  • Eligible participants will be recruited from Lions Befrienders (LB) senior activity centre and randomly assigned to the SinDance group or the control group.
  • Participants in the intervention group will receive one face-to-face briefing session and will be required to participate in the newly developed SinDance exergame 3 times a week for 6 weeks, while those in the control group will attend usual activities provided by the centers.
  • Outcomes will be measured at baseline, immediate after intervention, and 3 months from baseline.
Read the detailed description

SinDance will be structured as a two-phase study involving a multi-disciplinary team of software engineers, occupational therapist (OT), and research nurse (RN).

Phase 1: Development of the SinDance system will be undertaken by software engineers in collaboration with an OT and RN.

  • The SinDance intervention is a 6-week program consisting of one face-to-face briefing session provided by the Research Nurse (RN)/Research Assistant (RA) and SinDance exergaming. The dance movements will be choreographed for older adults based on local context and culture. The game design of SinDance will be developed on cross-platform game engine called Unity. Body movements will be captured via an external RGB camera. Using an open pose algorithm, the system will be able to track correct body movements based on image processing and body posture recognition, as well as provide active feedback on performance. This allows for real-time movement adjustments by the user to achieve higher compliance rating. Points will be awarded for each correct movement accomplished.
  • The SinDance intervention is designed as a leisure game to supplement the daily physical activities of older adults. There will NOT be strenuous or intense physical activities or any vigorous high-velocity movements in this intervention.

Considering that SinDance is a self-regulated exercise, to ensure safety during self-regulated exercise, dance choreography will be designed with varying levels of movement difficulty, speed and rhythm tempo to cater to the different needs of individual participants. The SinDance game interface will be designed with minimal action buttons to enhance usability and user- experience for older people to operate.

Phase 2: Pilot test to assess the effectiveness of SinDance exergame Study Design - A pilot two-arm randomized control trial with repeated measures will be conducted in Phase 2. Eligible participants will be recruited from Lions Befrienders (LB) senior activity centre. They will be randomly allocated to either intervention group or control group using block randomisation technique. The data will be collected at baseline, immediately after the intervention (i.e., 6 weeks from baseline) and 3 months from baseline.

Study Intervention

  • The exergame will run on a laptop, the display of game will be either on an external monitor or project to screen via a projector. To play the game, participants will dance to the dance moves shown on the screen and as they get each move right, they will be awarded points (please see attached picture for the proposed interface design and system setup). The RGB webcams will be used to capture body movements and provide immediate/spontaneous feedback on the correctness of the movements. It will be affixed to the laptop. The participants' faces will not be captured.
  • There will be no device for the participants to take home. The participants will only play the game in LB SACs (not in their homes).
  • For this study, the participant will play the game individually, and under the observation of a RA/RN to ensure safety. No group play will be conducted in the pilot study. Before playing, they will be briefed on how to play in a language they understand.

SinDance Group.

  • One face-to-face briefing session will be offered to participants in the SinDance group. The session will be conducted by the RN/RA. As part of promoting physical activity and safe exercise for older adults, the RN/RA will provide general guidance to older people on the benefits of physical activity (e.g.the recommended duration for physical activity, which will yield health benefits, and therefore, participants will play the exergame for 3 times a week and each session about 30 mins) and how to exercise safely (e.g. don't exercise if you feel unwell or very tired, wear appropriate footwear, warm up before exercise and cool down and stretch after exercise, etc.). This education will be provided to intervention group only. He/She will also teach the participants on how to navigate the SinDance exergame system, and how to choose between different levels of dance and play modes. It is estimated that the session will last for 20 minutes.
  • To achieve adequate exercise volume, participants will be asked to engage in the newly developed SinDance 3 times a week for 6 weeks. Each session will last for about 30-40 mins, including 5 mins warm up exercise before the game and 5 mins cool down exercise afterwards. Therefore, if the participant does not stop halfway through or end the game early, the actual playing time for each participant will be about 20-30 minutes.
  • To play the game, participants will dance to the dance moves shown on the screen (on the external monitor or the projected screen) and as they get each move right, they will be awarded points. The more accurate their moves are, the more points they get in the game.
  • During the gameplay, the participants will be instructed to stop and rest if they are tired, and to dance on their own without the physical assistance from others during their play. A RN/RA will be on site to observe the safety of exergaming and to help resolve technical issues as they arise.

Control Group.

  • Participants in the control group will attend usual activities offered by the senior activity centres. The control group will be offered an opportunity to play the SinDance exergame after completing the last data collection (i.e. 3-months from baseline).
Being tested
SinDance
Keywords
falls, activities of daily living, exercise, dance, exergame
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SinDanceBehavioural

    One face-to-face briefing session (20 min) will be offered to participants in the SinDance group as part of promoting physical activity and safe exercise for older adults.

    Participants will be asked to engage in SinDance 3 times a week for 6 weeks. Each session will last for about 30-40 mins, including 5 mins warm up exercise before the game and 5 mins cool down exercise afterwards.

    All the game play sessions will be conducted in LB centres. Each participant will play the game individually.

    To play the game, participants will dance to the dance moves shown on the screen (on the external monitor or the projected screen) and as they get each move right, they will be awarded points. The more accurate their moves are, the more points they get in the game.

    During the gameplay, the participants will be instructed to stop and rest if they are tired. A RN/RA will be on site to observe the safety of exergaming and to help resolve technical issues as they arise.

Study groups in NCT05887648
Study groupRoleWhat they receive
SinDanceExperimentalParticipants in the SinDance group will attend an educational briefing session on the importance of exercising, and participate in a 6-week SinDance exergame intervention
Receives: Behavioral: SinDance
ControlNo interventionParticipants in the control group will attend usual activities offered by the senior activity centres. The control group will be offered an opportunity to play the SinDance exergame after completing the last data collection (i.e. 3-months from baseline).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Fall Efficacy Scale International (short FES-I)

    Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).

    Measured: Baseline

  2. Short Fall Efficacy Scale International (short FES-I)

    Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).

    Measured: 6 weeks from baseline

  3. Short Fall Efficacy Scale International (short FES-I)

    Scores range from 7 to 28 and lower scores indicate a better outcome (lower fear of falling).

    Measured: 3 months from baseline

  4. 15-item Geriatric Depression Scale (GDS-15)

    Scores range from 0-15, and higher scores indicate a worse outcome (depression).

    Measured: Baseline

  5. 15-item Geriatric Depression Scale (GDS-15)

    Scores range from 0-15, and higher scores indicate a worse outcome (depression).

    Measured: 6 weeks from baseline

  6. 15-item Geriatric Depression Scale (GDS-15)

    Scores range from 0-15, and higher scores indicate a worse outcome (depression).

    Measured: 3 months from baseline

  7. Frenchay Activities Index (FAI)

    Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)

    Measured: Baseline

  8. Frenchay Activities Index (FAI)

    Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)

    Measured: 6 weeks from baseline

  9. Frenchay Activities Index (FAI)

    Scores range from 15-60 and higher scores indicate better outcome (better ability to engage in activities of daily living)

    Measured: 3 months from baseline

  10. Five times sit-to-stand test (FTSTS)

    A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)

    Measured: Baseline

  11. Five times sit-to-stand test (FTSTS)

    A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)

    Measured: 6 weeks from baseline

  12. Five times sit-to-stand test (FTSTS)

    A longer time taken to complete the test indicates a worse outcome (weaker functional lower limb muscle strength)

    Measured: 3 months from baseline

  13. Time Up & Go Test (TUG)

    A longer time to complete the test indicates a worse outcome (poorer mobility)

    Measured: Baseline

  14. Time Up & Go Test (TUG)

    A longer time to complete the test indicates a worse outcome (poorer mobility)

    Measured: 6 weeks from baseline

  15. Time Up & Go Test (TUG)

    A longer time to complete the test indicates a worse outcome (poorer mobility)

    Measured: 3 months from baseline

  16. Functional Reach Test

    A longer reach distance indicates a better outcome (better balance)

    Measured: Baseline

  17. Functional Reach Test

    A longer reach distance indicates a better outcome (better balance)

    Measured: 6 weeks from baseline

  18. Functional Reach Test

    A longer reach distance indicates a better outcome (better balance)

    Measured: 3 months from baseline

  19. Modified Barthel ADL Index

    Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)

    Measured: Baseline

  20. Modified Barthel ADL Index

    Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)

    Measured: 6 weeks from baseline

  21. Modified Barthel ADL Index

    Scores range from 0-20, and higher scores indicate a better outcome (functional independence in the domains of personal care and mobility)

    Measured: 3 months from baseline

Secondary outcomes (4)
  1. Attendance (for SinDance group only)

    Their attendance for each exergame session will be recorded

    Measured: Each session during the 6-week intervention (total of 18 sessions)

  2. Level of motivation (for SinDance group only)

    Participants will be asked to rate their level of motivation to play the exergame after each exergame session on a five-point Likert scale ranging from '1 = very low' to '5 = very high'.

    Measured: Each session during the 6-week intervention (total of 18 sessions)

  3. Level of enjoyment (for SinDance group only)

    Participants will be asked to rate their level of enjoyment during the exergame after each exergame session on a five-point Likert scale ranging from '1 = very low' to '5 = very high'.

    Measured: Each session during the 6-week intervention (total of 18 sessions)

  4. Duration of play (for SinDance group only)

    Their duration of play for each exergame session will be recorded

    Measured: Each session during the 6 week intervention (total of 18 sessions)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start5 Apr 2023
  3. Primary completion24 Jan 2024
  4. Study completion24 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomised into 2 groups - SinDance (interventional group) or control group. A computerised randomisation programme will generate the randomization list and a person independent from the study will prepare the sealed envelopes according to the generated randomisation list. After a participant is registered, a unique participant enrolment ID will be assigned to the participant. The envelope according to the enrolment ID will be opened on site and the participant will be allocated into either one of the two groups based on the randomisation list the group indicated.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887648
Sponsor's protocol ID
NUHS Seed Grant Call Sep 2021
Status last verified
May 2024
First submitted
9 May 2023
Last updated
14 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised study results and data will be available to researchers who request it as part of an IPD study or meta-analysis that has been prospectively registered and a protocol by a representative researcher is provided to verify the legitimacy of the request.

Questions about this trial

What is this clinical trial studying?

A study testing SinDance in people with Community-dwelling Older Adults, run by National University of Singapore at 5 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Fall Efficacy Scale International (short FES-I) (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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